Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Overall, 2022 phenylephrine retail sales reached $1.8 billion, compared with retail sales of $0.5 billion for pseudoephedrine.

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National Institute on Drug Abuse: Nora's Blog

JANUARY 6, 2025

8 Currently in the United States, methadone is only available from specialized opioid treatment centers, but studies piloting access through pharmacies have shown promise. 2022 Feb;23(2):212-223. 2022 Feb 1;231:109254. Epub 2022 Jan 18. Risk of dying was similarly low for both groups. doi: 10.1007/s11121-021-01321-9.

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The December calendar is packed with regulatory and industry meetings.

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. pharmacies and personal imports from India can be safe as well.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

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Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Legally the State of California – or, more accurately, a private litigant purporting to exercise state powers – has no such power, because warnings on OTC drugs must be approved by the FDA.

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Drug & Device Law

OCTOBER 10, 2023

2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Central Admixture Pharmacy Services, Inc.,

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Drug & Device Law

JULY 24, 2023

2022) (many other cases recognize this problem with class actions). the relationship between [plaintiff] and its pharmacy benefit manager. . . Apparently, massive loss of evidence was merely a “usual and customary service” of pharmacy benefit mangers nationwide. E.g. , Laudato v. EQT Corp. , 4th 256, 260 (3d Cir. 555, 565 (E.D.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

OCTOBER 6, 2022

20-cv-392, 2022 WL 4542043 (D.C. 29, 2022) (to be published in A.3d), 3d), the homeopathic products at issue were accurately labeled, but DC’s high court held that nonetheless consumers could be misled into believing that they were as effective as the FDA-approved products placed next to them on the pharmacy shelves.

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Drug & Device Law

JUNE 29, 2022

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., LLC , 2022 Minn. May 24, 2022), is unusual. The FDA approved the plaintiff’s 5 mg solution, and the only other FDA approved ephedrine solutions came in the 50 mg concentration. It was not FDA approved.

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